Hot Topics: Standards for PET Drugs—Chapter <823>

Originally published in 1998, General Chapter <823> describes requirements for the production and compounding of PET drugs, typically as injectable solutions in a multi-dose vial. Production is defined as the process of synthesis or formulation of a PET drug for investigational or research uses. Compounding is defined as the process of synthesis or formulation of a PET drug for use in pharmacy and medicine. Since the chapter's publication in 1998, technological, marketplace, and regulatory changes related to PET drugs have necessitated the chapter's revision.

In 2009, the U.S. Food and Drug Administration (FDA) published final regulations (the Final Rule) and an accompanying guidance document for PET Current Good Manufacturing Practices (CGMP). Once the FDA's Final Rule becomes effective on December 12, 2011, General Chapter <823> (as published in USP 32–NF 27) will officially constitute the minimum CGMP requirements for investigational and research PET drugs used in human subjects under an Investigational New Drug application or under the approval of a Radioactive Drug Research Committee. All other PET drugs will be subject to FDA's new CGMP requirements. It is important to note that the FDA Final Rule references General Chapter <823> in USP 32–NF 27. Once the current revision process for General Chapter <823> is completed and the chapter is published, USP will petition FDA to update the reference in its regulation. Until that is accomplished, investigational and research PET drug manufacturers will have to comply with the 1998 version of General Chapter <823> or the Code of Federal Regulations Title 21 Part 212 to meet CGMP requirements.

All comments to the revisions to Chapter <823> may be submitted to Dr. Ravi Ravichandran at USP823@usp.org by March 31, 2011.